FDA WARNING_LETTER - Las Dos Californias Inc DBA Dulceria los Cuates - October 27, 2021

On October 19-27, 2021, the FDA inspected Las Dos Californias Inc DBA Dulceria Los Cuates for Foreign Supplier Verification Program (FSVP) compliance, following previous inspections in 2018 and 2019. The inspection revealed significant violations of 21 CFR part 1, subpart L, and section 805 of the FD&C Act.

The company failed to develop, maintain, and follow an FSVP for imported foods, including tamarind candy and toasted pumpkin seeds. They did not conduct or document a hazard analysis for imported foods, specifically failing to document review and assessment of foreign supplier hazard analyses for "Chamoy" product and other suppliers. Furthermore, the company did not approve foreign suppliers based on performance and risk evaluations, nor did they establish written procedures for approving foreign suppliers or for ensuring appropriate foreign supplier verification activities for products like "Chamoy."

The company's November 15, 2021, response indicated they sought assistance to develop FSVPs and estimated providing records within eight weeks, but no additional documents have been received by the FDA. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz).